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Home » Authors » Mark McCarty

Articles by Mark McCarty

Artificial intelligence and digital health icons
MDMA Annual Meeting

Cassidy sees risk of hurried US legislation for AI

April 18, 2024
By Mark McCarty
One of the problems with the European Union’s Artificial Intelligence Act is that it spans all sectors of the E.U. economy, an approach that Sen. Bill Cassidy (R-La.) suggested is less than optimal in remarks to this year’s meeting of the Medical Device Manufacturers Association. Nonetheless, Cassidy said some in the Senate are keen to pass legislation without taking proper stock of the lack of congressional expertise, which runs the risk that hasty legislation may create more problems than it solves.
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Cloud/cybersecurity illustration

US House hearing includes calls for federal cybersecurity support

April 17, 2024
By Mark McCarty
With the recent hack of Change Healthcare back in the news, a committee of the U.S. House of Representatives took up the subject of cybersecurity, which included only a couple of mentions of medical devices. However, witnesses at the hearing emphasized the role of the federal government in thwarting foreign cybersecurity threats against health care facilities, with John Riggi of the American Hospital Association stating, “we need the [federal] government to go after bad actors overseas.”
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Gavel and FTC logo

Member of US House blasts FTC/DOJ merger guidelines

April 17, 2024
By Mark McCarty
The new merger guidelines released by the U.S. Department of Justice and the Federal Trade Commission have proven controversial on several fronts, but now the House of Representatives is weighing in. Rep. Roger Williams (R-Texas) said the guidelines fail to account for the importance of these transactions for small businesses seeking to grow and requested that the two agencies provide data that would demonstrate whether such concerns were considered in drafting those rules.
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U.S. at night from space with circuit board overlay

Telehealth legislation again on tap in US House of Representatives

April 17, 2024
By Mark McCarty
Telehealth received a much-needed boost from the COVID-19 pandemic, but normal reality has settled in and a number of telehealth bills have surfaced in the U.S. House of Representatives. However, Rep. Brett Guthrie (R-Ky.) advised other members of the House that a recent extension of temporary Medicare telehealth coverage added $2 billion to Medicare spending, a fact which he said forces legislators to ensure that “whatever we move out of committee is paid for.”
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1-10-abbott-heartmate3.png

Long-term use of Heartmate devices associated with obstruction

April 16, 2024
By Mark McCarty
The long-term use of ventricular assist devices is becoming a problem for at least some of these devices, as demonstrated by the recall of the Heartmate II and Heartmate 3 devices by Abbott Laboratories’ Abbott Vascular division due to obstruction of the outflow graft used to attach the device to the human heart.
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Cloud/cybersecurity illustration

US House hearing includes calls for federal cybersecurity support

April 16, 2024
By Mark McCarty
With the recent hack of Change Healthcare back in the news, a committee of the U.S. House of Representatives took up the subject of cybersecurity, which included only a couple of mentions of medical devices. However, witnesses at the hearing emphasized the role of the federal government in thwarting foreign cybersecurity threats against health care facilities, with John Riggi of the American Hospital Association stating, “we need the [federal] government to go after bad actors overseas.”
Read More
Gavel and vials

Decision Diagnostics CEO Berman hit with stiff prison sentence

April 15, 2024
By Mark McCarty
The U.S. Department of Justice announced that Keith Berman, formerly the CEO of Los Angeles-based Decision Diagnostics Corp., has received a prison sentence of seven years for misrepresenting the company’s developmental test for the SARS-CoV-2 virus during the height of the COVID-19 pandemic.
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CMS logo and website

US CMS eyes alternative to accountable care for FFS beneficiaries

April 15, 2024
By Mark McCarty
In the inpatient draft for fiscal 2025, the U.S. Centers for Medicare & Medicaid Services has proposed an accountable care model for beneficiaries on fee-for-service care, one which is designed to provide the coordination of care ordinarily seen only in accountable care organizations.
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Architectural pillars

Edwards comes up short in US case testing Hatch-Waxman safe harbor

April 12, 2024
By Mark McCarty
The Hatch-Waxman Act provides a safe harbor that allows importation of an FDA-regulated article that would otherwise be deemed a case of patent infringement so long as the importation is for purposes reasonably related to obtaining regulatory approval. Edwards Lifesciences Corp. sued Meril Life Sciences Pvt Ltd. for importation of heart valves in a manner that Edwards argued was infringement under Hatch-Waxman, but while the Federal Circuit ruled 2-1 against Edwards, the dissenting opinion recommended an appeal to a full 12-judge panel that could reverse this outcome.
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CMS logo and website

US CMS eyes new cutoff date for new tech add-on payments

April 12, 2024
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services has proposed a few significant changes to the new technology add-on program for the fiscal year 2025 inpatient prospective payment system, including a boost in NTAP rates for gene therapy services.
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